Model: 9901B
DI: D1259901B2
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Micro Applicators
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
37d0d478-59bf-49c9-98f3-7ddf9c47a734
Distribution Status:
In Commercial Distribution
DUNS Number:
541637603
Device Count:
1000
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
D1259901B8
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
D1259901B2
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Device ID:
D1259901B2
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
HIBCC
Item #3 - Device ID:
D1259901B0
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 35697
Name: Dental material application tool, single-use
Definition:
A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.
FDA Product Codes
KXR
Applicator, Resin